Healthy male/female adults
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Healthy male/female subjects ranging in age from 20 to 34, at informed consent. (2) Subjects having less than 25.0 kg/m2 of BMI. (3) Subjects with no smoking (not less than one year). (4) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects being under some kind of continuous medical treatment, including the study period. (2) Subjects who have periodically used health-specific / functional (e.g., gamma-aminobutyric acid, L. gasseri CP2305)/ health foods including supplements, which might affect the autonomic nervous system, stress, fatigue and brain function. (3) Subjects with incompatible chest (e.g., thick bodyhair, pacemaker-fitting) for heartbeat measurements. (4) Subjects with excessive alcohol intake. (5) Subjects with extremely irregular eating habits, and subjects having an irregular life rhythm with irregular shift work or midnight one. (6) Subjects who are under other clinical tests with some kind of medicine/food, or participated in those within four weeks before this study, or are planning to join those after the consent. (7) Subjects who are under a large stress condition with some kind of life event, such as house-moving, transfer, bereavement, etc., within three months before the agreement for this study and during the study period. (8) Subjects with any difficulty in giving up drinking since the day before the scheduled date of this study. (9) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (10) Subjects getting excessive exercise every day. (11) Subjects with a serious symptom of premenstrual syndrome. (12) Pregnant, possibly pregnant, and lactating women. (13) Subjects having some kind of drug and/or food allergy. (14) Subjects who break out in a rash from putting electrodes on the head and chest. (15) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitrax (symbol-digit coding, stroop, and shifting attention) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The Profile of Mood States Second Edition (Japanese short ver.) 2. Psychological questionnaire 3. Heartbeat | — |
Countries
Japan
Contacts
CPCC Company Limited Clinical Planning Department